Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003310824

FEI Number

3003310824

Entity Name

Ivoclar Vivadent Manufacturing GmbH

City/State/Country

NATURNO (BZ) Bolzano, IT

Establishment Address

Via Gustav Flora 32, NATURNO (BZ) Bolzano I-39025, IT

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

IVOCLAR VIVADENT (Owner Number: 8010208)

Owner / Operator Contact Address

175 Pineview Dr., Amherst, NY 14228, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

TelioCAD for M-Center TelioCAD for Milling Center Telio CAD for PlanMill Telio CAD for Cerec Telio CAD LT discs Telio CAD disc Telio CAD SR ORTHOLINGUAL DCL SR VIVODENT DCL SR Orthotyp DCL Candulor brand denture teeth Candulor Physioset TCR Candulor Bonartic TCR BlueLine SR ORTHOPLANE DCL IPS Style Ceram IPS Style Ceram One IPS Build-Up Liquid IPS Style Ceram Transpa IPS e.max CAD for Planmill IPS e.max CAD MT IPS e.max CAD LT IPS e.max ZirCAD for Inlab IPS e.max CAD Impulse IPS e.max CAD HT IPS e.max CAD for InLab IPS e.max ZirCAD for PlanMill IPS e.max CAD CEREC IPS e.max CAD IPS e.max ZirCAD CAD/CAM CEREC Starter Kit CAD/CAM PlanMill Starter Kit IvoBase Hybrid IvoBase High Impact SR Ivocap High Impact BasePlast Fibers AutoPlast Monomer BasePlast Monomer BasePlast Polymer Aesthetic Intensiv Color AutoPlast AutoPlast Polymer Triplex Cold Triplex Hot Aesthetic Cold Probase High Impact Hot XPLEX Probase Hot Probase Cold Aesthetic Hot Probase High Impact Cold SR Vivodent S PE SR Orthotyp S PE SR Vivodent S DCL SR Orthotyp S DCL SR Ortholingual S DCL PhysioSelect TCR BonSelect TCR Ivotion Dent Physiostar NFC Condyloform II NFC SR Orthotyp S SR Ortholingual S IPS e.max CAD Abutment Solutions IPS e.max CAD CER/inLab LT SR-IVOLEN TRAY MATERIAL SR-IVOLEN ProArt CAD Try-In SR Ivocron IPS e.max CAD Abutment Solutions- extra systems ProArt CAD Splint SR Orthotyp Candulor brands SR Vivodent Preference Posterior SR Ivostar Preference Anterior SR Gnathostar SR Vivodent A-D SR Orthotyp A-D IPS e.max ZirCAD MT Multi blocks IPS e.max ZirCAD MT discs IPS e.max ZirCAD Prime Esthetic IPS Ivocolor IPS Ivocolor Intro Kit IPS e.max Ceram Art Telio CAD Abutment Solutions- extra systems IPS e.max Ceram Selection IPS e.max Ceram IPS Empress Staining IPS e.max Ceram Power IPS e.max CAD Crystall Glaze Spray IPS e.max CAD Crystall Stains IPS e.max CAD Crystall Shades IPS e.max CAD Crystall Glaze Paste IPS e.max Ceram Intro Kit IPS e.max Ceram Glaze Spray SR Ivocap PhysioStar NFC Plus Bonartic II NFC Plus Condyloform II NFC Plus Spartan Solder Spartan Ceramic Solder d.SIGN 30 Colado NC

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EBG	Crown And Bridge, Temporary, Resin	Dental	Class 2	872.3770	2010-03-16
ELM	Denture, Plastic, Teeth	Dental	Class 2	872.3590	2004-01-14
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2016-05-24
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2007-11-14
EBI	Resin, Denture, Relining, Repairing, Rebasing	Dental	Class 2	872.3760	2012-05-24
EBI	Resin, Denture, Relining, Repairing, Rebasing	Dental	Class 2	872.3760	2007-11-14
EBI	Resin, Denture, Relining, Repairing, Rebasing	Dental	Class 2	872.3760	2004-10-06
ELM	Denture, Plastic, Teeth	Dental	Class 2	872.3590	2016-05-19
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2021-08-23
ELM	Denture, Plastic, Teeth	Dental	Class 2	872.3590	2008-04-17
ELM	Denture, Plastic, Teeth	Dental	Class 2	872.3590	2014-01-28
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2013-11-05
EBH	Material, Impression Tray, Resin	Dental	Class 1	872.3670	2005-07-07
EBG	Crown And Bridge, Temporary, Resin	Dental	Class 2	872.3770	2007-11-14
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2007-11-14
PNP	Dental Abutment Design Software For Dental Laboratory	Dental	Class 2	872.3630	2019-09-09
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2019-09-09
NDP	Accessories, Implant, Dental, Endosseous	Dental	Class 1	872.3980	2003-06-26
ELM	Denture, Plastic, Teeth	Dental	Class 2	872.3590	2007-11-15
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2015-12-17
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2015-10-29
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2020-11-30
PNP	Dental Abutment Design Software For Dental Laboratory	Dental	Class 2	872.3630	2020-11-30
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2007-11-14
EBI	Resin, Denture, Relining, Repairing, Rebasing	Dental	Class 2	872.3760	2007-11-14
ELM	Denture, Plastic, Teeth	Dental	Class 2	872.3590	2012-05-22
EJH	Alloy, Metal, Base	Dental	Class 2	872.3710	2006-10-20

Official Correspondent

Dana Glina

US Agent Details

Anderjeet Gulati Business: Ivoclar Vivadent Email: anderjeet.gulati@ivoclar.com Phone: (716) 2642046

Related Public Records

Same Entity

IVOCLAR VIVADENT

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3034244245	DSSM AG	Schaan, LI
3011511773	Candulor Dental GmbH	Rielasingen-Worblingen Baden-Wurttemberg, DE
3024046877	DSSM GmbH	Lindau Bavaria, DE
3004362235	IVOCLAR VIVADENT, INC.	Diezmo, Cabuyao City Laguna, PH
1316092	IVOCLAR VIVADENT, INC.	AMHERST, NY, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K070591	Union Dental S.A./Unidesa.Odi	REPLICA, ORTOLUX TOP, ODIPAL, ODILUX, ODIDENT, VITACRILIC, NATURE'S BEST, DENTAL ACRYLIC TEETH	2007-05-11
K915276	Nobelpharma USA, Inc.	DENTURE PLASTIC TEETH,76 ELM	1992-02-03
K143656	H.C. Starck Ceramics GmbH	StarCeram® Z-Nature, StarCeram® Z-Smile	2015-07-09
K800400	Dentsply Intl.	MAXUM DENTURE RESIN	1980-03-12
K033020	Cmp Industries, LLC	IMPAK ACRYLIC REPAIR RESIN LIQUID	2003-12-19

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0017-2017	Ivoclar Vivadent, Inc.	2	Zenostar MT Color Impulse blue, Art. no. 681165 Product Usage: For coloring dental porcelain
Z-0018-2017	Ivoclar Vivadent, Inc.	2	Zenostar MT Color Impulse brown, art. no. 681169 Product Usage: For coloring dental porcelain
Z-0019-2017	Ivoclar Vivadent, Inc.	2	Zenostar MT Color Impulse grey, art. no. 681167 Product Usage: For coloring dental porcelain
Z-0020-2017	Ivoclar Vivadent, Inc.	2	Zenostar MT Color Impulse violet, art. no. 681166 Product Usage: For coloring dental porcelain
Z-0021-2017	Ivoclar Vivadent, Inc.	2	Zenostar MT Color A1 60ml, art. no. 681050, Product Usage: For coloring dental porcelain

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003310824. Last updated year: 2026. Please use registration number 3003310824 when referencing this establishment in official correspondence.